Artivion: FDA grants HDE for use of AMDS Hybrid Prosthesis

Artivion (AORT) announced that the U.S. FDA has granted a Humanitarian Device Exemption for use of the AMDS Hybrid Prosthesis in acute DeBakey Type I dissections in the presence of malperfusion. The AMDS is the world’s first aortic arch remodeling device for use in the treatment of acute DeBakey Type I aortic dissections.